Samsung Electronics gained approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its blood pressure monitoring application. The company said the MDFS granted the Software as a Medical Device (SaMD) license to its Samsung Health Monitor app.
According to Samsung, the grant made the app the first-ever “government-cleared, over-the-counter, and cuffless blood pressure monitoring application.”
The South Korean firm said that its health monitor app allows users to quickly and conveniently measure and track blood pressure when paired with the Galaxy Watch Active2’s advanced sensor technology.
Taejong Jay Yang said that the app could potentially help millions of people affected by high blood pressure. Yang is the Corporate SVP and Head of Health Team, Mobile Communications Business at Samsung Electronics. He added that the app shows how Samsung integrates its world-class hardware with its latest software innovations to revolutionize mobile experience.
Samsung Health Monitor
With Samsung Health Monitor, the Galaxy Watch Active2 could simply measure the user’s blood pressure anytime after calibrating with a traditional blood pressure cuff. The Heart Rate Monitoring sensors present on the device tracks and analyzes pulse waves, which gives blood pressure readings.
The program ensures accuracy by requiring users to calibrate their device at least every four weeks.
Additionally, the Galaxy Watch Active2 features Samsung’s latest health and wellness capabilities. Aside from monitoring heart rates, the device could also track users’ exercise, stress, sleep patterns as well as give health tips to improve well-being.
Samsung said that it plans to launch the health monitor app on the Galaxy Watch active2 within the third quarter. The company added that it would expand the app to upcoming Galaxy Watch devices.
The ministry last February revised its guidelines to allow medical-purpose mobile applications alone to advance the country’s ICT industry. Currently, 35 mobile applications have acquired a SaMD license from the ministry.
According to the ministry, for apps to meet all requirements of standard blood pressure monitors, they should not exceed 8mmHg for the standard deviation and 5mmHg for the average difference. Meanwhile, pulse accuracy should be within five percentage points. The ministry said that the Samsung Health Monitor app met all the performance requirements.